Systems and methods for providing a shear reduction system for an orthopedic cast

ABSTRACT

The present invention relates to orthopedic casts. In particular, some implementations relate to a cast system having one or more underlayment components that are disposed between an internal surface of a cast or splint and a body part that is covered by the cast or splint. While the underlayment components can include any suitable element, in some cases, they include a compression sock and a padding layer. Additionally, in some such cases, the compression sock and the padding layer are capable of moving (at least somewhat) with respect to each other such that shearing movement between the skin of a casted appendage and the cast itself is configured to take place between the padding layer and the compression sock (and/or another portion of the underlayment). Additionally, in some cases, one or more components of the underlayment comprise an antimicrobial material, such as a bamboo fabric. Other implementations are also described.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent ApplicationSer. No. 61/845,921 (Attorney Docket No. 21907.2), filed Jul. 12, 2013,and entitled “SYSTEMS AND METHODS FOR PROVIDING AN ORTHOPEDIC DEVICE,”and claims priority to U.S. Provisional Patent Application Ser. No.61/978,891 (Attorney Docket No. 21907.3), filed Apr. 13, 2014, andentitled “SYSTEMS AND METHODS FOR PROVIDING A TOTAL CONTACT ANDOFFLOADING CAST;” the entire disclosures of which are both herebyincorporated by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to orthopedic casts. In particular, someimplementations of the present invention relate to one or morecomponents of a total contact cast system that can be used in thetreatment of an appendage, such as a leg or foot. Indeed, in someimplementations, the described cast system is configured to support apatient's foot and leg, while offloading weight from a sore, ulcer, orwound on the patient's foot.

2. Background and Related Art

People across the world suffer from ulcerations and injuries to one orboth of their feet. For instance, as many people suffering from diabetesalso suffer from poor blood flow in their appendages, such people can beat a relatively high risk of developing sores, wounds, or ulcers ontheir feet—especially on the soles of their feet. Such sores, ulcers,and other wounds can dramatically affect an individual's life, limitingthe individual's ability to walk, work, and play, and costing theindividual (or others) relatively large amounts of money and time spentin, and for, recovery. Additionally, in some extreme cases, such sores,ulcers, and wounds can lead to amputation, which can dramaticallyincrease healthcare costs, and otherwise complicate life.

One important factor in healing foot wounds is offloading the patient'sweight from the wound. However, as many individuals (includingdiabetics) suffer from neuropathy (or nerve damage in one or moreappendages), many such individuals often cannot feel the pain that isnormally associated with foot sores, ulcerations and/or wounds. As aresult, some such individuals may not be highly motivated by pain toreduce pressure applied to a damaged portion of the foot, which mayultimately lead to tissue breakdown, ulceration, and other damage.Accordingly, some such individuals may continue to place detrimentalamounts of weight on their foot and/or a wound thereon—thus causing thewound to further deteriorate, and thus, increasing the chances ofinfection and other comorbidities.

Several casts, boots, and other devices have been developed to treatindividuals suffering from foot ulcerations, sores, and other wounds.While some such devices have been useful in the treatment of suchwounds, such devices are not necessarily without their shortcomings.Indeed, some conventional devices for treating foot wounds arerelatively: hard to put on, hard to take off, uncomfortable,non-breathable, ineffective at offloading weight from wounds in abnormallocations, hard to use with other apparatus (e.g., negative pressurewound therapy), and/or are otherwise difficult to use or ineffective attreating these wounds.

Thus, while techniques currently exist that are used to treat footwounds, ulcerations, and sores, challenges still exist, including thosementioned above. Accordingly, it would be an improvement in the art toaugment or even replace current techniques with other techniques.

SUMMARY OF THE INVENTION

The present invention relates to orthopedic casts. In particular, someimplementations of the present invention relate to one or morecomponents of a total contact cast system that can be used in thetreatment of an appendage, such as a leg or foot. Indeed, in someimplementations, the described cast system is configured to support apatient's foot and leg, while offloading weight from a wound on thepatient's foot and distributing such weight to one or more otherportions of the patient's leg (e.g., a forefoot, arch, heel, Achillestendon, cone of the lower leg, etc.).

While the described orthopedic cast system can comprise any suitablecomponent or characteristic, in some implementations, it includes a“clam-shell” cast, a foot support, one or more cast underlayments,and/or a footplate/boot. With respect to the clam-shell cast (or cast),the cast can comprise any suitable component or characteristic thatallows it to be applied over a first surface of a patient's body (e.g.,a posterior portion of a patient's lower leg or calf), to be appliedover a portion of the patient's foot, and then to be applied over asecond surface of the patient's body (e.g., an anterior portion of apatient's lower leg or shin), wherein the second surface issubstantially opposite to the first surface. Indeed, in some cases, thecast comprises an elongated piece of hardenable casting material that isconfigured to extend substantially vertically along a longitudinal axisof a posterior portion (or calf) of a patient's lower leg, bend aroundthe patient's heel, extend along a sole of the patient's foot, bend upover one or more of the patient's toes, extend across a dorsal portionof the patient's foot, and extend vertically along an anterior portion(or shin) of the patient's lower leg.

While an anterior portion and a posterior portion of the cast can beattached to each other and a patient's appendage (e.g., lower leg) inany suitable manner (e.g., via one or more elastic bands, pieces ofcasting material, belts, cords, straps, ties, fasteners, pieces of tape,and/or any other suitable connector), in some embodiments, the castcomprises one or more straps and/or wings that are configured to extendfrom the anterior and/or the posterior portion of the cast and tooverlap the opposite portion of the cast. While these wings and/orstraps can perform any suitable function, in some instances, theyconnect various portions of the cast together, strengthen the cast,and/or help spread weight across a portion of an appendage (therebyoffloading weight from a wound on the appendage).

With regard to the foot support, the foot support can comprise anysuitable padding that allows a portion of the patient's weight to beoffloaded from a wound on the sole (or another portion) of the patient'sfoot. In some implementations, the padding comprises at least two layersof padding, with each layer having a different durometer value. As aresult, some such implementations are able to cushion a foot, whileoffloading pressure from a wound on the foot.

In some implementations, the foot support defines (or is configured toreadily be modified to define) an offloading hole that is configured tocorrespond in position to (and otherwise reduce pressure that is appliedto) a wound on a patient's foot. While such an offloading hole can bedefined in the foot support in any suitable manner, in someimplementations (depending on the type of foot support selected), thehole is cut in the support (e.g., free hand, with a scissors, a punch,knife, etc.), is made by removing portions of the support along one ormore perforated lines in the support, and/or by adding to the footsupport an additional padding layer defining an offloading hole.

In some implementations, the foot support further comprises a toe guardthat is configured to be disposed within the cast and to extend over aportion of one or more of a patient's toes. While the toe guard cancomprise any suitable characteristic that allows it to function asdescribed, in some cases, the toe guard comprises a portion having a boxshape, a rounded shape, and/or another suitable shape that isresiliently (or rigidly) formed in the foot support to help protect apatient's toes.

With respect to the cast underlayment, the underlayment can comprise anysuitable material that is configured to be disposed between an internalsurface of the cast and the skin of an appendage (or other body part)within the cast. Indeed, in some implementations, the underlaymentcomprises one or more layers of an antimicrobial material (e.g., ananti-fungal and anti-bacterial material). Some examples of such materialinclude, but are not limited to, bamboo fabrics, bamboo rayon,silver-coated fabric (e.g., silver-coated poly(ethylene terephthalate),silver-coated rayon, silver-coated polyester, iodine incorporated cloth,etc.), copper-coated fabric, silver/copper-coated fabric,silver/copper/nickel-coated fabric, silver/copper/tin-coated fabric,and/or any other material with one or more antimicrobial and/oranti-odor characteristics. In some implementations, however, theunderlayment comprises a fabric containing bamboo.

While the underlayment can comprise any suitable component, in someimplementations, the underlayment comprises a padding layer, acompression layer, and/or a bandage (or localized padding) layer. Wherethe underlayment comprises a padding layer, the padding layer cancomprise any suitable material, including, without limitation, a paddedsock or stockinette (e.g., a sock or stockinette comprising bamboofabric). Where the underlayment comprises a compression layer, thecompression layer can comprise any suitable material, including acompression sock or stockinette (e.g., a sock or stockinette comprisingbamboo fabric) that is configured to provide any suitable amount ofpressure when worn on an appendage (e.g., between about 8 and about 25mmHg).

In some implementations in which the underlayment comprises 2, 3, 4, 5,or more layers of one or more materials, the underlayment functions as amulti-layer shear reduction system, allowing two or more layers of theunderlayment to move independent of each other, and thereby allowshearing movement between the skin of a casted appendage and the castitself to take place between the multiple layers of the underlayment(e.g., the padding sock and the compression sock), instead of at thesurface of the patient's skin.

With reference to the footplate/boot, some implementations of thedescribed cast system (and its various components) are configured to beused (e.g., walked on) without a footplate or boot. In otherimplementations, however, one or more components of the cast are usedwith a footplate and/or a boot. With respect to the footplate, thefootplate can comprise any suitable feature that it to support apatient's foot and/or offload weight from a wound on the sole of thepatient's foot. Indeed, in some instances, a posterior portion of thefootplate defines a recess that is configured to cradle and/or correctlyposition the patient's heel on the footplate. In some case, thefootplate further comprises a cam-shaped undersurface. In such cases, aneccentric portion of the cam-shaped undersurface of the footplate can bedisposed in any suitable location, including, without limitation, beingdisposed anteriorly, posteriorly, laterally, medially, and/or in themiddle of (or with respect to) the length of the footplate.

With respect to the boot, the boot can comprise any suitablecharacteristic or component that allows it to support a portion of apatient's leg. Indeed, in some implementations, the boot comprises afootplate with one or more upright supports that allow the footplate tobe attached to a patient's leg. While the upright supports can compriseany suitable component, in some implementations, the upright supportsare configured to be attached to one or more attachment mechanisms,which can include, but are not limited to, one or more straps, cords,and/or other devices that are capable of securing the upright supportsto a patient's leg. Additionally, in some implementations, the uprightsupports include one or more flaps (e.g., lateral flaps, medial flaps,posterior flaps, anterior flaps, etc.) that help distribute pressurefrom the upright supports across a portion of the patient's leg. In suchembodiments, the flaps can have any suitable characteristic. Indeed, insome embodiments, one or more of the internal surfaces of the flaps(e.g., the surfaces that are configured to interface with the cast)comprises a material, texturing, and/or other feature that allows it tomaintain its position with respect to the cast (e.g., as the patientwalks in the boot).

While the described systems and methods may be particularly useful inthe area of treating one or more sores, ulcerations, and/or other woundson the sole (and other portions) of an individual's foot, those skilledin the art can appreciate that the described apparatus, systems, andmethods can be used in a variety of different applications and in avariety of different areas of manufacture to treat a wide range ofinjuries to an individual's appendages (e.g., arms, hands, fingers,toes, legs, etc.), and in any suitable location. Indeed, in someimplementations, the described antimicrobial underlayment (e.g.,compression sock and/or padding sock), foot support, and/or cast (ormodified versions thereof) are used in an arm cast, a hand cast, and/orin any other suitable cast or splint system.

These and other features and advantages of the present invention will beset forth or will become more fully apparent in the description thatfollows. Furthermore, the features and advantages of the invention maybe learned by the practice of the invention or will be obvious from thedescription, as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

In order that the manner in the above recited and other features andadvantages of the present invention are obtained, a more particulardescription of the invention will be rendered by reference to specificembodiments thereof, which are illustrated in the appended drawings.Understanding that the drawings depict only typical embodiments of thepresent invention and are not, therefore, to be considered as limitingthe scope of the invention, the present invention will be described andexplained with additional specificity and detail through the use of theaccompanying drawings in which:

FIG. 1A illustrates a perspective view of a representative embodiment ofan orthopedic cast system;

FIG. 1B illustrates a cross-sectional view of a representativeembodiment of the orthopedic cast system;

FIG. 1C illustrates a cross-sectional view of a representativeembodiment of the orthopedic cast system;

FIG. 2A illustrates a top plan view of a representative embodiment of aclam-shell cast;

FIG. 2B illustrates a side elevation view of a representative embodimentof the clam-shell cast disposed on a patient, wherein the cast isillustrated as being semi-transparent to provide a non-limitingillustration of a relation between the cast and the patient's leg;

FIGS. 2C-2E each illustrates a top plan view of representativeembodiments of the clam-shell cast;

FIGS. 3A-3B each illustrates a top plan view of representativeembodiments of the clam-shell cast in an assembled (or asubstantially-assembled) position;

FIGS. 4A-4D each illustrates a top plan view of representativeembodiments of the clam-shell cast;

FIG. 4E illustrates a perspective view of a representative embodiment ofthe clam-shell cast;

FIGS. 5A-5C each illustrates a side elevation view of representativeembodiments of the clam-shell cast in the assembled position;

FIG. 6A illustrates a top, exploded view of a representative embodimentof the clam-shell cast;

FIG. 6B illustrates a top plan view of a representative embodiment ofthe clam-shell cast;

FIG. 6C illustrates a top, exploded view of a representative embodimentof the clam-shell cast;

FIG. 7A illustrates a top plan view of a representative embodiment ofthe clam-shell cast;

FIG. 7B illustrates a side elevation view of a representative embodimentof the clam-shell cast disposed on the patient;

FIG. 7C illustrates a top, exploded view of a representative embodimentof the clam-shell cast;

FIG. 8 illustrates a side elevation view depicting a representativeembodiment of the clam-shell cast;

FIG. 9A illustrates a perspective view of a representative embodiment ofa foot support;

FIG. 9B illustrates a perspective view of the foot support according toa representative embodiment, wherein the foot support defines anoffloading hole;

FIG. 9C illustrates a side elevation view of a representative embodimentof the foot support;

FIG. 9D illustrates a perspective view of a representative embodiment ofthe foot support;

FIG. 9E illustrates a side elevation view depicting a representativeembodiment of the foot support;

FIG. 9F illustrates a perspective view of a representative embodiment ofthe foot support;

FIG. 9G illustrates a side cross-sectional view of the foot support inaccordance with a representative embodiment;

FIG. 9H illustrates a side elevation view of a foot disposed on arepresentative embodiment of the foot support;

FIG. 9I illustrates a perspective view of the foot support comprising aplurality of perforations in accordance with a representativeembodiment;

FIG. 9J illustrates a top plan view depicting a foot disposed on arepresentative embodiment of the foot support;

FIGS. 9K-9L each depicts a top plan view depicting representativeembodiments of the foot support;

FIG. 9M illustrates a top plan view of a representative embodiment ofthe foot support;

FIG. 9N illustrates a side elevation view of a representative embodimentof the foot support;

FIG. 9O illustrates a side elevation view of a representative embodimentof the foot support, wherein the foot support is configured for use as arepresentative embodiment of a cast walker;

FIG. 9P illustrates a perspective view of the foot support defining anoffloading hole;

FIG. 9Q illustrates a side elevation view depicting a representativeembodiment of the foot support;

FIG. 10A illustrates a cross-sectional view of a representativeembodiment of the orthopedic cast system;

FIG. 10B illustrates a plan view of a representative embodiment of acompression sock;

FIG. 10C illustrates a plan view of a representative embodiment of apadding sock;

FIGS. 10D-10F each illustrates a plan view of representative embodimentsof the clam-shell cast;

FIG. 10B illustrates a plan view of a representative embodiment of apiece of additional padding;

FIGS. 11A-11C each illustrates various side elevation views ofrepresentative embodiments of a cast underlayment comprising additionalpadding;

FIG. 11D illustrates a cross-sectional view depicting a representativeembodiment of the cast underlayment;

FIG. 12A illustrates a top plan view of a representative embodiment of afootplate;

FIGS. 12B-12D each illustrates a side elevation view of representativeembodiments of the footplate;

FIG. 12E illustrates a side elevation view of the footplate attached tothe cast in accordance with a representative embodiment;

FIG. 12F illustrates a side elevation view of a representativeembodiment of the footplate;

FIG. 12G illustrates a side elevation view of the footplate attached tothe cast in accordance with a representative embodiment;

FIG. 12H illustrates a front elevation view of the footplate inaccordance with some embodiments of the invention;

FIG. 12I illustrates a side elevation view of a representativeembodiment of a boot;

FIG. 12J illustrates a front elevation view of a representativeembodiment of the boot;

FIG. 12K illustrates a side elevation view of a representativeembodiment of the boot;

FIG. 12L illustrates a side elevation view of a representativeembodiment of the boot;

FIGS. 12M-12O each illustrates a side elevation view of representativeembodiments of a boot flap;

FIG. 12P illustrates a top plan view of the representative embodiment ofthe boot;

FIG. 12Q illustrates a side elevation view in which the footplate isattached to a shoe in accordance with some embodiments of the invention;

FIG. 13 depicts a representative embodiment of a method for applying thecast system; and

FIGS. 14A-14F each illustrates various views of the representative castsystem at different points in an application process according to someembodiments of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to orthopedic casts. In particular, someimplementations of the present invention relate to one or morecomponents of a total contact cast system that can be used in thetreatment of an appendage, such as a leg or foot. Indeed, in someimplementations, the described cast system is configured to support apatient's foot and leg, while offloading weight from a wound on thepatient's foot. In this regard, the term wound may be used herein torefer to a sore, ulcer, cut, incision, laceration, puncture, pustule,skin graft, stitched portion of skin or flesh, bruise, boil, contusion,broken bone, and/or any other suitable injury that can be covered,offloaded, cushioned, protected, and/or otherwise be treated with one ormore components of the described cast system.

In the disclosure and in the claims, the term lower leg (and variationsthereof) may be used to refer to any portion of a patient's leg that islocated distal to the patient's knee.

The term hardenable casting material (and variations thereof) may beused herein to refer to a suitable known or novel material that isconfigured to be pliable and moldable when being applied to a patient,and that can readily be hardened to function as an orthopedic cast.

The terms patient and individual (and variations thereof) may be usedherein to refer to any person or other subject that can wear or use anyand/or all portions of the described cast system.

The term sock (and variations thereof) may be used to herein to refer toa sock, stockinette, sleeve, sheath, casing, covering, tube, wrap,and/or similar object.

The term total contact cast may be used herein to refer to an orthopediccast having a shape that substantially conforms to a portion of apatient's lower leg so as to spread weight from the patient's leg acrossa larger surface area than the typical contact areas of the sole of thepatient's foot.

Although the described orthopedic cast system can comprise any suitablecomponent or characteristic that allows it to cover and protect awounded portion of a person's body, FIG. 1A shows a representativeembodiment of the orthopedic cast system 10. More specifically, FIGS.1B-1C) show some embodiments in which the cast system 10 comprises aclam-shell cast 12, a foot support 14, and a cast underlayment 16 eachof which can be used independently or in connection with each otherand/or a footplate or a boot (such as the boot 18 shown in FIG. 1A). Toprovide a better understanding of the described orthopedic cast systemand its various components, the following disclosure is grouped intofive subheadings, namely “CLAM-SHELL CAST,” “FOOT SUPPORT,” “CASTUNDERLAYMENT,” “FOOTPLATE/BOOT,” and “ASSOCIATED METHODS.” In thisregard, the utilization of the subheadings is for convenience of thereader only, and is not to be construed as being limiting in any sense.

Clam-Shell Cast

With respect to the cast 12, the cast can comprise any suitablecharacteristic that allows it to extend over a first surface of apatient's appendage (e.g., lower leg), over an end of the appendage, andover a second surface of the appendage, which is substantially oppositeto the first surface. Indeed, because, in at least some embodiments, afirst portion of the cast is configured to cover a first surface of anappendage and a second portion of the cast is configured to cover asecond surface of the appendage that is substantially opposite to thefirst surface of the appendage (thus sandwiching the appendage (oranother suitable body part) between two portions of the cast), the castis sometimes called a clam-shell cast.

While the cast 12 can comprise any suitable component that allows it tofunction as described herein, FIGS. 2A-2B show some embodiments in whichthe cast 12 comprises an elongated piece of hardenable casting material18 (or the elongated casting material 18). While the elongated castingmaterial can have any suitable component, FIGS. 2A-2B show that, in someembodiments, the casting material 18 has a first portion 20 that isconfigured to extend over a posterior portion 22 of a patient's lowerleg 24 (e.g., calf); a second portion 26 that is configured to extendover the patient's heel 28 and extend across a length of the sole 30 ofthe patient's foot 32; and a third portion 34 that is configured toextend over an anterior end of the patient's foot (e.g., toes 36), runacross a dorsal portion 38 of the patient's foot, and extend up over ananterior portion 40 of the patient's lower leg 24 (e.g., shin).

The clam-shell cast 12 can comprise any suitable hardenable castingmaterial that allows the cast to substantially conform to the shape ofan appendage (e.g., lower leg 24) during application of the cast, and tothen harden in that shape to form an orthopedic cast. In this regard, bysubstantially conforming to the shape of an appendage, the cast can helpspread weight from a portion of the appendage (e.g., the sole 30 of afoot 32) to a larger portion of the appendage. In other words, in someembodiments, the cast itself allows its patient to offload weight from afoot wound and to spread such weight to other portions of the patient'slower leg.

Some examples of hardenable casting materials include, but are notlimited to, any known or novel and suitable: fiberglass casting material(e.g., fiberglass that has been impregnated with polyurethane and/oranother suitable material; fiberglass that is coated with and/orotherwise comprises silver, copper, nickel, iodine, bamboo, and/oranother suitable antimicrobial material and/or anti-odor material; anyother suitable type of fiberglass casting; and/or combinations thereof),hardenable bandaging (e.g., cotton bandaging that is coated withplaster, polyester bandaging that is covered with plaster, any othersuitable casting material that is configured to a harden afterapplication), a thermoplastic casting material, etc.), a polypropylenecasting material, a carbon fiber casting material, a hardenableantimicrobial material (e.g., plaster or another suitable hardenablematerial covering: a bamboo cloth, a bamboo rayon, a polyester made frombamboo, another fabric comprising bamboo, a silver-coated fabric (e.g.,silver-coated poly(ethylene terephthalate), silver-coated rayon,silver-coated polyester, etc.), a copper-coated fabric, asilver/copper-coated fabric, a silver/copper/nickel-coated fabric, asilver/copper/tin-coated fabric, an iodine incorporated cloth, and/orany other suitable material having one or more antimicrobial and/oranti-odor features), a casting material (e.g., fiberglass, cottonbandaging, and/or any other suitable casting material) that isimpregnated with and/or otherwise comprises any suitable antibiotic,bactericide, and/or other antimicrobial ingredient, which may include,without limitation, penicillin, amikacin, gentamicin, kanamycin,netimicin, tobramycin, streptomycin, spectinomycin, geldanamycin,herbimycin, rifaximin, ertapenem, doripenem, imipenem, meropenem,defadroxil, cefazolin, cefalotin, cephalexin, and/or any other suitableantimicrobial), casting tape, and/or any other suitable material that isconfigured to be formed around a portion of a patient's body (e.g., thepatient's leg and foot) and then to be hardened to form an orthopediccast. Indeed, in some embodiments, the hardenable casting materialcomprises a known or novel fiberglass casting material that isconfigured to begin hardening once it has been exposed to air and/orwater.

Where a portion of the cast 12 (e.g., the first portion 20) isconfigured to extend over a first surface of an appendage (e.g., a calf)and another portion of the cast (e.g., the third portion 34) isconfigured to extend over a second, substantially opposite, portion ofthe appendage (e.g., a shin), the various portions of the cast can beattached to each other in any suitable manner that allows the cast tofunction as a total contact cast. In some embodiments, the variousportions of the cast are attached to each other and/or an appendage(e.g., a lower leg) through the use of one or more wings, portions ofthe cast that are configured to overlap other portions of the cast,straps, belts, cords, bands, pieces of casting material, mechanicalengagements, non-mechanical engagements, fasteners, frictionalengagements, hook and loop fasteners, snaps, buckles, slides, tieshinges, flexible portions, and/or any other suitable connector. By wayof non-limiting illustration, FIG. 2B shows an embodiment in which thedotted lines 42 indicate an overlap of various portions of the cast 12(i.e., a wing 44). Additionally (and jumping a little ahead in thefigures), FIG. 4E shows that, in some embodiments, one or more straps 48and 50 of the cast 12 are configured to attach to each other and/or aportion of the cast 12 via a fastener 113 (e.g., a hook and loopfastener).

In embodiments in which the cast 12 comprises a wing 44, the wing canperform any suitable function. Indeed, in some instances, the wings areconfigured to attach at least one portion of the cast to at least oneother portion of the cast and/or to cradle, and distribute pressureacross, a portion of the patient's appendage (e.g., lower leg 24).

The cast 12 can comprise any suitable number of wings 44 (e.g., 1, 2, 3,4, 5, 6, or more) that extend laterally from, or past, at least onelateral edge of the elongated casting material 18. For instance,returning to FIG. 2A, that figure shows an embodiment in which the cast12 comprises 4 wings 44 that each extend laterally (on either side ofthe cast) past a lateral edge 46 of a portion of the elongated castingmaterial 18.

Where the cast 12 comprises one or more wings 44, the wings can bedisposed in any suitable location that allows a portion of the wings toextend (e.g., before the cast is hardened on a patient) laterally past alateral edge 46 of the elongated casting material 18. Some examples ofsuitable locations include, but are not limited to, either side (e.g., aright and/or left side) of the first portion 20, second portion 26,and/or third portion 34 of the elongated casting material. By way ofnon-limiting illustration, FIGS. 2A, 2C, and 2D show some embodiments inwhich a plurality of wings 44 extend past a lateral edge 46 (on both aright-hand and a left-hand side) of both the first portion 20 and thethird portion 34 of the elongated casting material 18.

Where the cast 12 comprises one or more wings 44, the wings can have anysuitable shape that allows them to act as described herein. Someexamples of suitable wing shapes include, without limitation, a fletchor fin shape (e.g., as shown in FIG. 2A), a rectangular or quadrilateralshape (e.g., as shown in FIGS. 2C and 2D), a trapezoidal shape (e.g., asshown in FIG. 2E), a polygonal shape, a triangular shape, an ovularshape, an irregular shape, and/or any other shape that allows the wingto function as intended.

The wings 44 can also be any suitable length (or width) that allows themto function as intended. In some embodiments, one or more wings areconfigured to overlap at least one of another wing and a portion of theelongated casting material 18. For instance, FIG. 3A illustrates anembodiment in which the elongated casting material 18 and the wings 44from the first portion 20 of the cast 12 are not necessarily configuredto overlap with either the elongated casting material or another wingwhen the cast is worn on a lower leg 24 of a desired size. In contrast,FIG. 3B illustrates an embodiment in which the elongated castingmaterial 18 and/or the wings 44 are configured to overlap at least oneof another wing and the elongated casting material when worn on a lowerleg 24 of a desired size. Specifically, FIG. 3B illustrates anembodiment in which at least one wing 44 overlaps another wing 44.

Where the cast 12 comprises a strap, the cast can comprise any suitablenumber of straps, including, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, ormore. Additionally, the straps can be disposed in any suitable location(e.g., extending from either or both lateral sides of the first portion20, the second portion 26, and/or the third portion 34). In this regard,FIGS. 4A-4C show various embodiments in which the cast 12 comprises oneor more straps 48 that are disposed at the first portion 20 of theelongated casting material 18 with one or more foot straps 50 disposedat the second portion 26 of the elongated casting material 18.Additionally, FIG. 4C shows that, in at least some embodiments, the cast12 comprises one or more straps 48 that are disposed at the thirdportion 34 of the elongated casting material 18. Furthermore, while thestraps can overlap each other, be separated from each other, and/or haveany other suitable relationship to each other, FIGS. 4A-4C illustratethat, in some embodiments, the straps 48 and/or 50 can be placed anysuitable distance apart from each other that allows the cast 12 tofunction as intended.

While the straps 48 can have any suitable shape (e.g., be rectangular,belt-shaped, triangular, rounded, polygonal, irregular, symmetrical,asymmetrical, ribbon-like, cord-like, rope-like, and/or any othersuitable shape), FIG. 4B shows an embodiment in which at least some ofthe straps 48 are substantially rectangular. In this regard, while thestrap ends can be any suitable shape (e.g., pointed, rounded, polygonal,irregular, triangular, trapezoidal, tapered, etc.), FIG. 4C shows arepresentative embodiment in which the strap ends 52 are substantiallytrapezoidal in shape.

Where the cast 12 comprises one or more straps 48, the straps can beconfigured to secure the cast on an appendage (e.g., lower leg 24)and/or any other suitable body part, in any suitable manner. Forinstance, FIG. 5A shows an embodiment in which one or more straps 48 areconfigured to circumscribe a portion of the cast 12. Additionally, FIG.5B shows an embodiment in which at least some of the straps 48 areconfigured to extend only partially around a part of the cast 12.Moreover, FIG. 5C illustrates that, in some embodiments, a plurality ofthe straps 48 are configured to interdigitate with each other (e.g., byangling the straps across a portion of the elongated casting material18). Furthermore, while the straps can run substantially perpendicularto a length (or a longitudinal axis) of the elongated casting material18 (e.g., as shown FIG. 4C), in some embodiments, the straps areconfigured to run at an angle (e.g., an oblique and/or an obtuse angle)with respect to the length of the elongated casting material. In someembodiments, as the straps are configured to be wrapped perpendicularly(and/or at another suitable angle) to the length of the elongatedcasting material, this “cross-strapping” both secures the cast to anappendage and significantly increases the cast's strength.

The straps 48 and wings 44 can be made of any suitable material thatallows the cast 12 to function as intended. Some examples of suchmaterials include, but are not limited to, one or more hardenablecasting materials, fabrics, materials comprising hook and loopfasteners, and/or any other suitable materials. In some embodiments,however, the straps and/or wings comprise a hardenable casting material(e.g., a fiberglass impregnated with polyurethane and/or any other newor novel hardenable material configured to be used with fiberglasscasting materials).

Where the cast 12 comprises one or more straps 48, wings 52, and/or anyother suitable connectors, such components can be attached to anysuitable portion of the elongated casting material 18 (e.g., the firstlength 20, the second length 26, the third length 34, and/or any othersuitable portion) and in any suitable manner. In this regard, someexamples of suitable methods for attaching one or more connectors (e.g.,straps and/or wings) to the cast include, but are not limited to,attaching such connectors to the cast by forming the cast andconnector(s) together; by forming the cast and connector(s) of the samepiece and/or pieces of material; via one or more adhesives, tapes, typesof stitching, mechanical fasteners, non-mechanical fasteners, frictionalfasteners, etc.; by tightening the connector(s) onto the cast; bywrapping the connector(s) around a portion of the cast; by passing theconnector(s) through one or more loops on the cast; and/or any othersuitable method). Indeed, FIG. 6A shows that, in some embodiments, oneor more pieces of strap material 54 are inserted between two or morelayers 56 of the elongated casting material 18. In contrast, FIG. 6Bshows straps 48 can be attached to the elongated casting material viastitching 58 and/or one or more other suitable manners. In still anotherexample, FIG. 6C shows that, in some embodiments, one or more pieces ofstrap material 54 are placed on top of and are adhered or otherwiseattached to (e.g., via stitching and/or any other suitable method) toone or more layers 56 of the elongated casting material 18.

The various components of the cast 12 (e.g., the elongated castingmaterial 18, the wings 44, and/or straps 48) can be any suitable size.Indeed, while the elongated casting material can be any suitable width,in some embodiments, it has a width (e.g., width W as shown in FIG. 6B)that is between about 4 cm and about 40 cm, or any sub-range thereof(e.g., between about 15 cm and about 20 cm). Additionally, while theelongated casting material can be any suitable length (e.g., length L asshown in FIG. 6B), in some embodiments, it has a length between about 50cm and about 255 cm, or any sub-range thereof (e.g., between about 127cm and about 158 cm). Moreover, while the straps can be any suitablewidth (e.g., strap width SW, as shown in FIG. 6B), in some embodiments,the straps have a width between about 0.5 cm and about 35 cm, or anysub-range thereof (e.g., between about 5 cm and about 13 cm).Furthermore, while the straps can be any suitable length (e.g., straplength SL, as shown in FIG. 6B), in some embodiments, the straps have alength between about 20 cm and about 90 cm, or between any sub-rangethereof (e.g., between about 35 cm and about 76 cm).

The various components of the cast 12 can also have any suitablethickness. Indeed, in some embodiments, the elongated casting material18, straps 48, and wings 44 are between about 1 mm and about 3 cm thick.In other embodiments, the various components of the cast have athickness that falls in any suitable sub-range of the aforementionedrange (e.g., between about 2 mm and about 4 mm thick). Moreover,although, in some embodiments, the wings and/or straps have a thicknessthat is substantially equal to or greater than the thickness of theelongated casting material, in other embodiments, the wings and/orstraps have a thickness that is thinner than that of the elongatedcasting material. Indeed, in some embodiments, the wings and/or strapshave a thickness that is between: about 1% and about 99%, or between anysub-range of such range (e.g., between about 20% and about 70% orbetween about 40% and about 60%) of the thickness of the elongatedcasting material.

The various components of the cast 12 can comprise any suitable numberof layers of hardenable casting materials. Indeed, in some embodiments,the various cast components (e.g., the elongated casting material 18,the wings 44, and/or straps 48) comprise between about 1 and about 30layers of hardenable casting material (e.g., fiberglass knitting). Inother embodiments, the various components comprise between about 2 andabout 16 layers of casting material. In still other embodiments, thevarious components comprise any suitable number of layers of castingmaterial that fall within any of the aforementioned ranges. Forinstance, some embodiments of the elongated casting material 18 comprisebetween about 12 and about 17 layers of casting material (e.g., from 14to 16 layers). Additionally, some embodiments of the straps comprisebetween about 3 and about 7 layers of casting material (e.g., from 4 to6 layers).

In addition to the aforementioned characteristics, the clam-shell cast12 can be modified in any suitable manner that allows it to protectand/or offload weight from a portion of a patient's body. In one exampleof a suitable modification, some embodiments of the elongated castingmaterial 18 comprise one or more features that allow it to bendrelatively easily (e.g., before the cast hardens) in one or more places(e.g., around a patient's heel, toes, etc.). In this regard, the castcan be configured to bend in any suitable manner, including, withoutlimitation, by including one or more cuts, notches, perforations, scoredportions, pre-creased fold lines, hinges, thinned portions, and/or othersimilar features (which may be referred to herein as a foldingaccommodation) in a location where it is intended that the elongatedcasting material will bend to conform to an appendage. By way ofillustration, FIG. 7A shows an embodiment in which the elongated castingmaterial 18 includes at least one notch 60 that extends into theelongated casting material at a place where the elongated castingmaterial is configured to bend around a patient's heel 28. In anotherexample, FIG. 4B shows an embodiment in which the cast 12 comprises oneor more cuts 62 that extend towards a center of the elongated castingmaterial 18, where the elongated casting material is configured to bendaround the patient's heel and toes.

In another example of an optional modification, some embodiments of thecast 12 define one or more holes (e.g., holes to provide ventilationand/or holes for medical tubing; collectively and individually referredto as ventilation holes or holes). In this regard, the cast can defineany suitable number of ventilation holes, the holes can be of anysuitable size, and the holes can be disposed in any suitable location.In one example, the cast comprises between 1 and 10,000 holes, or anysuitable number of holes that fall within that range (e.g., between 1and 200).

While the ventilation holes in the cast 12 can be any suitable size thatallows air and/or medical tubing (e.g., for negative pressure woundtherapy or another suitable purpose) to pass through the castingmaterial while allowing the cast to maintain a desired rigidity, in someembodiments the holes have an inner diameter or width of between about 1mm and about 20 cm. In other embodiments, the cast defines one or moreholes having an inner diameter or width between about 0.3 cm and about 3cm. In still other embodiments, the cast defines one or more holes inany suitable sub-range of the aforementioned ranges (e.g., between about0.4 cm and about 2 cm).

While the ventilation holes can be disposed in the cast 12 in anysuitable location (e.g., in the elongated piece of casting material 18,in one or more wings 44, in one or more straps 48, and/or in any othersuitable location), in some embodiments, the holes are configured to bedisposed in the cast so as to provide ventilation and/or access tomedical tubing to a calf, sole of a foot, dorsal portion of a foot,heel, shin, and/or other portion of an appendage. By way ofillustration, FIGS. 7A and 7B show some embodiments in which the cast 12comprises ventilation holes 64 in a calf section 66, dorsal foot section68, and shin section 70 of the cast 12.

In another example of a suitable modification, some embodiments of thecast 12 comprise or are configured to comprise one or more reinforcedportions. In such embodiments, any suitable portion of the cast can bereinforced (e.g., a toe, foot, ankle, calf, proximal portion, etc.). Byway of non-limiting illustration, FIGS. 7A-7B show some embodiments inwhich an ankle portion 72 of the cast 12 comprises a reinforcement 74.In any case, however, reinforcement of portions of the cast can beprovided in any suitable manner. Indeed, in one example, after the castis placed on an appendage a strap, ribbon, tie, and/or belt is placed onone or more portions of the cast. In another example, after the cast isplaced on an appendage, casting material is wrapped around the cast in adesired location. In still another example, one or more reinforcementsare added to the cast by placing additional layers 76 of castingmaterial (as shown in FIGS. 7B-7C) in desired locations along a lengthof the elongated casting material 18 (e.g., before and/or after the castis fit to a patient).

In another example of a suitable modification (which is not shown),instead of being configured to extend directly over the shin and calf ofa patient (e.g., as shown in FIG. 7B), the elongated casting material 18is configured to run down a lateral portion of a patient's lower leg,wrap over a portion of the patient's foot (e.g., heel 28 and/or anothersuitable portion), and extend back up over a medial portion of thepatient's lower leg (or vice versa).

In still another example of a suitable modification (which is notshown), the cast 12 is configured to extend over one or more otherappendages of a patient (e.g., an arm, finger, torso, etc.). Indeed, insome embodiments, the cast is configured to extend over a posteriorportion of a patient's forearm, wrap over a distal end of the patient'shand (e.g., over the distal end of the patient's fingers and/or with oneor more of the patient's fingers extending through a corresponding holeor holes in the casting material), and to extend over an anteriorportion of a patient's forearm.

In yet another example of a suitable modification, in some embodiments,the elongated casting material 18 is formed (at least partially) into apreformed boot before being applied to a patient's lower leg. In somesuch embodiments, the elongated casting material comprises a hardenablecasting material (e.g., a thermoplastic casting material, a plastercasting material, a fiberglass casting material, etc.) that can besoftened (e.g., via application of heat, water, a solvent, and/or othersuitable element or process) to be conformed to the shape of thepatient's lower leg, and that can then be hardened to form an orthopediccast.

In even another example of a suitable modification, while someembodiments of the elongated casting material comprise a singlecontinuous strip of material that extends from a first surface of anappendage (e.g., a calf), around an end of the appendage (e.g., a heel),and over a second surface (e.g., shin) of the appendage, which issubstantially opposite to the first surface, some embodiments of thecast comprise two or more separate pieces that are configured to bemolded and/or hardened over opposing surfaces of an appendage (e.g.,over a calf and a shin, an anterior and posterior portion of a forearm,etc.). By way of illustration, FIG. 8 depicts an embodiment in which thecast 12 comprises a splint 78 that includes a first 80 and a secondportion 82 of hardenable casting material that are joined by at leastone strap 48. In this regard, while FIG. 8 shows that, in someembodiments, the first 80 and second 82 portions of the casting materialabut each other, in some other embodiments (similar to the discussionabove relating to FIGS. 3A and 3B), the first and/or second portions ofthe casting material overlap each other (or stop short of overlappingwith each other) when placed on a desired appendage. Additionally, whileFIG. 8 shows an embodiment in which the splint comprises a first 80 anda second 82 discrete portion, the splint can comprise any suitablenumber of pieces, including, without limitation, 1, 2, 3, 4, 5, 6, ormore. Indeed, in some embodiments, the splint comprises a single pieceof the elongated casting material, with one or more wings, straps,and/or portions of the casting material overlapping and/or configured tooverlap another portion of the elongated casting material when it isapplied to an appendage.

In another example, some embodiments of the described cast 12 compriseboth a hardenable casting material (e.g., that can be formed around aportion of an appendage, such as a sole of a foot) and another material(e.g., one or more plastics, vulcanized rubbers, metals, polymers, wood,ceramics, and/or other materials) forming part of a preformed cast. Insome such embodiments, the various materials can be connected with eachother in any suitable manner, including, without limitation, through theuse of one or more straps, hinges, types of stitching, mechanicalfasteners, adhesives, tapes, frictional engagements, and/or any othersuitable connectors. While such a cast can perform any suitablefunctions, in some embodiments, the preformed portions of the cast allowthe cast to be placed on a patient relatively quickly, while theportions formed from a hardenable casting material allow the cast to betailored to fit a patient and to thereby spread weight across a portionof the cast to offload weight from a wound covered by the cast.

In another example, the cast 12 can comprise (or otherwise be used with)a cast walker; a walking heal; a walking pedestal; a walking shoe; oneor more reinforcements (e.g., one or more pieces of metal, plastic,ceramic, wood, rubber, and/or other suitable material) in a foot portionof the cast; an orthopedic insert; a footplate; a cast boot, slipper,shoe, sandal, slide, and/or other footwear comprising a footplate;and/or any other suitable structure that allows a patient to walk on alower leg that is covered with the cast.

In another example, the described cast 12 is configured to be walked onand/or otherwise used without the use of a boot 18, shoe, and/orfootplate (as discussed below). In such embodiments, the cast can beconfigured in any suitable manner that allows it to be used without aboot, shoe, or footplate, including, without limitation, by be made witha casting material and/or a sufficient amount of the casting materialthat prevents the cast from breaking and/or unduly bending during use.In other embodiments, as discussed above, the cast comprises one or morereinforcements in one or more portions of the cast (e.g., a footportion, an ankle portion, etc.).

In even another example, some embodiments of the cast 12 do not includethe use of casting material that is spiraled along an appendage and thecast itself. In some other embodiments, however, after the elongatedpiece of hardenable casting material 18 is applied to an appendage,hardenable casting material (and/or any other material) is spirallywrapped around a portion (if not all of) the cast.

In still another example, while the cast 12 is described herein for useas a total contact cast (e.g., for use in the treatment of sores,ulcers, and/or any other suitable wound on a foot), the cast can bemodified to be used for any other suitable purpose. Indeed, in someembodiments, the cast is configured to extend up a patient's leg, pastthe patient's knee. In other embodiments, the cast is used forprotecting an appendage (e.g., leg, foot, toe, arm, hand, finger, etc.).with a broken and/or fractured bone, while the bone heals. In yet otherembodiments, the cast is configured to be used in trauma situations inwhich a cast needs to be applied to a patient quickly. In yet otherembodiments, the cast is used for: post-surgical applications,post-fracture applications, protection of macerated tissue, closedreduction, covering an incision, immobilization of an appendage,negative pressure wound therapy, and/or for any other suitable purpose.

In yet another example of a suitable modification, some embodiments ofthe casting material of the described cast 12 (e.g., those comprisingone or more antibiotics, bactericides, silver, copper, nickel, iodine,and/or any other suitable antimicrobial material) are used to make anysuitable known or novel cast, splint, and/or other protective casting.Indeed, in some embodiments, the described casting material comprisingone or more antimicrobial materials is used to form an orthopedic castin which fiberglass, cotton, and/or another suitable material is wrappedaround a body part and hardened to form a cast.

In addition to the characteristics previously mentioned, the describedclam-shell cast 12 can have several features. Indeed, as someembodiments of the clam-shell cast are configured to fold onto a firstsurface of an appendage, extend around an end of the appendage, and thenfold back over a second surface of the appendage, which is substantiallyopposite to the first surface, some such embodiments of the describedcast differ from some conventional casts in that the elongated castingmaterial 18 of the current cast 12 is not spirally wound or wrappedaround an appendage or rolled or slid on to the appendage as a sock,stockinette, or sleeve.

In another example, as some embodiments of the described cast 12 areconfigured to substantially conform to the shape of an appendage, somesuch embodiments can be relatively effective at spreading pressureacross the appendage and thereby offloading weight from a woundedportion of the appendage.

In another example, as some embodiments of the described cast 12 haveopenings (e.g., on the sides of the toes, along the sides of the cast,via ventilation holes 104, via openings knitted and/or otherwise formedin the casting material, etc.), the described cast can allow for betterventilation than some competing casts. As a result, some embodiments ofthe described cast can manage moisture better than can some conventionalcasts. Accordingly, some embodiments of the described cast can betterreduce the problems associated with uncontrolled moisture (e.g.,maceration, soft tissue necrosis, etc.) than can some conventionalcasts.

In yet another example, some embodiments of the described cast 12 allowa patient wearing the cast to heal (e.g., have a foot wound heal) whilestill being able to walk. In another example, by wearing someembodiments of the described cast, a patient is able to keep unduepressure off a foot wound, even if the patient is not purposefullytrying to do so. In even another example, some embodiments of thedescribed cast are configured to eliminate and/or reduce the propulsivephase a patient's gate and/or shorten the patient's stride length, thusreducing the potentially damaging forces that can be placed on a woundas the patient walks.

In still another example (mentioned briefly above), some embodiments ofthe described cast 12 do not require that the cast (like someconventional total contact casts) be spirally wound around an appendage,or slid or rolled over the appendage like a sleeve, sock, orstockinette. As a result, some such embodiments of the described castmay be applied more quickly than some conventional total contact casts.Moreover, as some embodiments of the described cast can be applied to anappendage while the patient is sitting up or in another comfortableposition, some embodiments of the cast can be applied more convenientlythan some conventional total contact casts that require a patient to bemoved onto the patient's belly or into another uncomfortable position.

Foot Support

With respect to the foot support 14, the foot support comprises anorthotic that can comprise any suitable characteristic or component thatallows it to offload at least some weight from a foot wound and/orprovide padding to a portion of a foot 32. While the foot support can bedisposed in any suitable location, in some embodiments, the foot supportis configured to be disposed between a patient's foot and an interiorsurface of a cast (e.g., the cast 12 and/or any other suitable known ornovel cast).

The foot support 14 can be any suitable shape, including, but notlimited to, being square, rectangular, polygonal, symmetrical,irregular, circular, elliptical, foot shaped, shaped to contour to aportion of a foot, the shape of a portion of a foot, and/or any othersuitable shape that allows it to perform its intended function. In someembodiments, however, FIG. 9A shows the foot support 14 comprises aquadrilateral shape. In contrast, FIG. 9B shows that, in some otherembodiments, the foot support 14 comprises an elongated quadrilateralshape.

While the edges of the foot support 14 can have any suitable shape(e.g., terminating at a right angle, being rounded, being chamfered,tapering, being feathered, etc.), FIG. 9B shows an embodiment in whichthe at least some of the foot support's edges 83 end substantially atright angles. Additionally, FIGS. 9A and 9C show some embodiments inwhich the edges 83 of the foot support 14 are at least partiallybeveled. In such embodiments, the foot support's edges can be beveled atany suitable angle (e.g., at an angle Θ, including, without limitation,at an angle between about 1° and about 89°, or within any sub-rangethereof (e.g., between about 50° and about 70°, as shown in FIG. 9C).

The foot support 14 can comprise any suitable material that allows it toprovide padding to and/or to otherwise support a portion of a patient'sfoot. In this regard, the foot support can comprise any suitable type ofplastic, polymer, metal, ceramic, wood, synthetic material, naturalmaterial, padding, foam, anti-bacterial material (e.g., one or morebamboo materials, bamboo rayons, silver-coated poly(ethyleneterephthalate), silver-coated rayon, silver-coated polyester, othersilver-coated materials, iodine-incorporated materials, copper-coatedmaterials, silver/copper-coated materials, silver/copper/nickel-coatedmaterials, silver/copper/tin-coated materials, etc.), and/or otherantimicrobial material (e.g., as discussed above) and other suitablematerial that allows it to perform its intended purpose. Where the footsupport comprises padding, the foot support can comprise virtually anysuitable type of padding, including, without limitation, closed cellpadding, open cell padding, polymer padding (e.g., polypropylene,polyethylene, polyurethane, etc.), p-cell foam, x-static foam, feltedfoam, foam, polyurethane foam, silicon, gel, cotton, vinyl, polyvinylchloride, ethylene vinyl acetate, cork, combinations thereof, and anyother suitable material. Indeed, in some embodiments, the paddingmaterial comprises p-cell foam and/or crepe foam, wherein at least oneof the foams is optionally covered with felt and/or another suitablematerial.

Although some embodiments of the foot support 14 comprise a single typeor layer of padding material, in other embodiments, the foot supportcomprises a plurality of padding materials (e.g., 2, 3, 4, 5, or more).In such embodiments, the padding materials can be disposed in anysuitable manner (including, without limitation, by having some of thepadding materials be localized to particular locations (e.g., pressurepoints) on a foot and/or having the various padding materials bedisposed in layers). In this regard, FIGS. 9C and 9D show someembodiments in which the foot support 14 comprises a first padding layer84. In contrast, FIGS. 9E-9G show some embodiments in which the footsupport 14 comprises the first padding layer 84 and a second paddinglayer 86, wherein both layers extend across a significant portion, ifnot all, of the foot support. FIGS. 9F and 9G, however, show someembodiments in which the foot support 14 comprises the first paddinglayer 84 (e.g., a crepe padding) with one or more additional layers(e.g., of a p-cell foam 88 and/or another foam 90), localized around anoffloading hole or recess 92 (hereinafter referred to as a hole or anoffloading hole).

Where the foot support 14 comprises multiple layers of paddingmaterials, the various padding layers can have any suitablecharacteristic. For instance, where the foot support 14 comprisesmultiple layers of padding, the various layers can be joined in anysuitable manner, including, without limitation, by being integrallyformed together, via an adhesive, with a tape, through a hook and loopfastener, via heat welding, through stitching, and/or any other suitablemanner.

While various portions of the foot support 14 can be malleable,semi-malleable, and/or non-malleable, in some embodiments, the footsupport is malleable or pliable. In such embodiments, the foot support(or portions thereof) can have any suitable durometer value. Forinstance, some embodiments of the foot support comprise a padding layerhaving a durometer value between about 5 and about 120, or a durometervalue that falls within any suitable sub-range thereof (e.g., adurometer value between about 30 and about 60), depending on theparticular application of the foot support.

In some optional embodiments in which the foot support 14 comprisesmultiple layers of padding, the various padding layers each comprise apadding that has a different durometer value. Indeed, while, in someembodiments, the first padding layer 84 is softer than the secondpadding layer 86, in some preferred embodiments, the second paddinglayer is softer than the first padding layer. In this regard, thedifference between the durometer value of the first padding layer andthe second padding layer can be any suitable amount, including, withoutlimitation, a value that is less than about 60, or any suitablesub-range thereof (e.g., a durometer value that is less than about 30).For instance, some embodiments of the foot support comprise a firstpadding layer having a durometer value of about 55±10 and a secondpadding layer having a durometer value of about 30±10. In some suchembodiments, the first layer can provide needed support, while thesecond layer provides padding (e.g., for blood flow) and a desired levelof comfort. Additionally, in some embodiments in which the foot support14 comprises an offloading foot support (or a foot support defining anoffloading hole 92), the durometer value(s) of the padding layer and/orpadding layers are configured to help to offload weight/pressure from afoot wound while distributing such weight/or to other portions of apatient's foot.

In some embodiments, the foot support 14 comprises a toe guard that isconfigured to cover, cushion, and/or otherwise protect one or more of apatient's toes from being rubbed against a portion of the cast system 10(e.g., the cast 12) and becoming macerated or otherwise injured. Whilethe toe guard can comprise any suitable shape that allows it to fulfillits intended purpose, in some embodiments, it comprises a rounded end(e.g., an end having a J-shaped appearance, when viewed from its side),a box end (e.g., an end with a bottom surface, an end surface that runssubstantially orthogonally to the bottom surface, and a top surface thatruns substantially orthogonally to the end surface), a triangular end, aflat end (e.g., an end having a substantially flat surface that runssubstantially orthogonally to (or at another suitable angle with respectto) a bottom surface of the foot support, giving the foot support anL-shaped appearance), and/or any other suitable shape that allows thetoe guard to extend under one or more of a patient's toes, over (and/orin front of) a distal end of the toes, and/or over a dorsal portion ofone or more of the toes. Indeed, FIGS. 9G-9H show some embodiments inwhich the toe guard 94 comprises a substantially J-shaped end 96.

In some embodiments, the shape of the toe guard 94 is substantiallyresilient, such that the toe guard's shape (e.g., a J-shaped appearance)is retained when the toe guard is at rest, or (said differently) whenthe shape of the toe guard is not being retained by an external force orobject, such as a sock, a cast, underlayment, tape, bands, straps, ties,etc.). In other words, in some embodiments, the toe guard ismanufactured to maintain its shape, even when the toe guard is separatedfrom all other components of the described casting system 10.

While the toe guard 94 can be formed in any suitable manner that allowsit to fulfill its intended purpose and to resiliently retain its shape,in some embodiments, the toe guard's shape (e.g., a resilient J shape,L-shape, etc.) is formed in the foot support via a heating process(e.g., forming the toe guard's shape with: a hot curling iron, pressingthe foot support into a desired shape under the application of heat,etc.), a molding process, an extrusion process, and/or any othersuitable process.

In some embodiments, the shape of the toe guard 94 is rigid orsemi-rigid. In such embodiments, the toe guard can for formed with anysuitable material (e.g., one or more rigid or semi-rigid plastics,polymers, metals, ceramics, rubbers, plastics, synthetic materials,woods, supports, braces, etc.) and in any suitable manner (e.g., viamolding, extrusion, bending, and/or any other suitable process).

In some embodiments, the foot support 14 comprises an offloading hole 92(e.g., as shown in FIG. 9F) and/or is otherwise configured to be easilycustomizable. Indeed, in some embodiments, the foot support is formedwith one or more offloading holes. In other embodiments, however, thefoot support is configured such that a portion of the foot support canbe removed to form an offloading hole or depression in a locationcorresponding to a wound on the sole 30 of a patient's foot. In thismanner, the foot support can reduce the amount of pressure that isapplied to a foot wound.

Where the foot support 14 is easily customizable, portions of the footsupport can be removed in any suitable manner, including, withoutlimitation, by removing portions of the foot support with scissors, aknife, a punch, and/or another cutting instrument. In some embodiments,however, the foot support comprises one or more perforated portions thatare easily torn, cut, and/or otherwise separated to release one or moreportions of the foot support. While such perforations can be disposed inany suitable location and in any suitable pattern, FIG. 9I shows anembodiment in which a sole portion 98 of the foot support 14 comprises aperforated pattern or grid 100 that allows select portions of the footsupport to be removed to offset weight from (and to reduce pressure on)a foot wound. While FIG. 9I shows that some embodiments of theperforated grid 100 comprise a pattern of perforations in which at leasttwo perforations run substantially perpendicular to each other, in otherembodiments, the perforations run in any other suitable manner (e.g., inone or more circular or elliptical patterns, in one or more polygonalpatterns, at any angle with respect to each other, and/or otherwise). Byway of non-limiting illustration, FIG. 9P shows an embodiment in whichthe foot support 14 defines an octagonal offloading hole 92.

The foot support 14 can be any suitable size that allows it support aportion of a patient's foot 32 and/or to fit in a cast (e.g., cast 12and/or any other suitable known or novel cast), shoe, and/or boot. Forinstance, while the foot support can be sold at any suitable length, insome embodiments, the foot support has an initial length (IL, as shownin FIG. 9J) between about 8 cm and about 40 cm, or that falls within anysub-range thereof (e.g., between about 25 cm and about 35 cm).Additionally, while the foot support can be produced to have anysuitable initial width (IW), in some embodiments, the foot support hasan initial width between about 2.5 cm and about 25 cm, or within anysub-range thereof (e.g., between about 10 cm and about 15 cm).Furthermore, while the toe guard 94 can extend posteriorly any suitableamount from an anterior end of the foot support, in some embodiments,the toe guard has a length (TGL) between about 0 cm and about 25 cm, orwithin any sub-range thereof (e.g., between about 2.5 cm and about 8cm). Indeed, as shown in FIG. 9H, in some embodiments, the foot support14 is of a sufficient length to allow a patient's toe to be spacedsomewhat away from (e.g., posterior to) the toe guard 94. In thismanner, the toe guard can further reduce and/or prevent maceration of apatient's toes, as tends to occur in some conventional total contactcasts. Moreover, the foot support can be any suitable thickness (T, asshown in FIG. 9H). Indeed, in some embodiments, the foot support has athickness between about 0.1 cm and about 2.5 cm, or that falls withinany sub-range thereof (e.g., between 0.3 cm and 1.5 cm).

In some embodiments, the foot support 14 is further configured such thatits size (e.g., length and/or width) is easily customizable for use withpatients having varying foot sizes. While the foot support can beconfigured to be resized (and thereby become a custom offloadingorthotic) in any suitable manner (e.g., by comprising a material that iscut relatively easily by a cutting instrument), in some embodiments, thefoot support comprises perforations along one or more of its edges(e.g., its lateral edges and posterior edge). By way of illustration,FIGS. 9K-9L show some embodiments in which the foot support 14 comprisesa plurality of perforations 102 along its edges to allow the length(e.g., IL) and/or width (e.g., IW) of the foot support to be reduced bycutting or tearing the foot support at such perforations. In thisregard, while FIGS. 9K-9L shows some embodiments in which theperforations 102 comprise relatively straight lines, in some otherembodiments, the perforations have any other suitable shape, including ashape that allows the foot support 14 to be easily modified tosubstantially track at least a portion of a patient's foot print.

In addition to the aforementioned characteristics, the foot support 14can be modified in any suitable manner that allows it to offload weightfrom a foot wound and/or provide padding to a portion of a foot 32. Inone example of a suitable modification, the shape of the toe guard 94 ismodified to help the toe guard conform to one or more of a patient'stoes. While the toe guard can be modified any suitable manner, FIG. 9Kshows an embodiment in which, from a top plan view, the toe guard 94 isconfigured to slope from a patient's big toe (not shown in FIG. 9K)towards the patient's smallest toe (not shown in FIG. 9K). Similarly,FIG. 9L shows an embodiment in which, from a top plan view, the toeguard 94 is configured to curve from right to left, and vice versa.

In another example of a suitable modification, in some embodiments, thefoot support 14 defines one or more ventilation holes. While these holescan be defined in any suitable portion of the foot support, FIGS. 9K-9Lshow some embodiments in which the foot support 14 defines ventilationholes 104 in the support's toe guard 94 and/or sole portion 98.

In another example, although some embodiments of the foot support 14 arecompletely open around the support's lateral, medial, and/or posterioredges, in some other embodiments, the foot support includes one or moresidewalls. In this regard, such sidewalls can be disposed in anysuitable location on the foot support (e.g., so as to extend around anysuitable length of a lateral edge, a medial edge, and/or a posterioredge of the foot support as well as to extend up to any suitable heighton a patient's foot and/or leg. While such sidewalls can perform anysuitable function, in some embodiments, one or more sidewalls are usedto provide additional protection and/or wound-pressure offloading to apatient's foot and/or leg. Additionally, in some embodiments, thesidewalls and/or toe guard 94 optionally define one or more offloadingholes 92 that are placed (e.g., via cutting, tearing, separatingperforated lines, etc.) in the foot support at a position correspondingto one or more wounds on a patient's foot or leg—thus allowingweight/pressure to be offloaded from such wounds and distributed toother portions of the patient's lower leg. In any case, while theoptional sidewalls can be formed in any suitable manner, FIGS. 9M-9Nshow some embodiments in which the sidewalls 106 are formed with (or areotherwise attached to) the foot support 14, such that the sidewalls areresiliently (and/or rigidly or semi-rigidly) maintained in position atone or both sides of the toe guard 94.

In another example, the foot support 14 comprise or is otherwise usedwith a die, carbon paper, and/or other pressure sensitive material thatallows a user (e.g., a medical practitioner) to readily identify theposition of a wound when a foot 32 is placed on the foot support. Inthis manner, the position of an offloading hole 92 in the foot supportcan readily be determined.

In another example, the foot support 14 and/or toe guard 94 areoptionally modified to comprise one or more pads, walls, and/or otherseparators that are configured to extend (e.g., vertically or otherwise)between two or more of a patient's toes. In this example, suchseparators can perform any suitable function, including, withoutlimitation, helping with ventilation, cushioning the toes, preventingone toe from rubbing against another, and/or otherwise protecting thepatient's toes. Indeed, in some embodiments, such separators furthercomprise and/or are configured to be modified to comprise one or moreoffloading holes 92 that can be positioned to offload weight from awound between a patient's toes.

In another example, one or more portions of the foot support 14 comprisean adhesive, mechanical fastener, frictional fastener, and/or otherfastening mechanism that is configured to attach the foot support to anysuitable object (e.g., a footplate, an internal surface of a cast (e.g.,the described cast 12 and/or any other suitable cast), an underlayment16 component (e.g., an internal and/or external surface of aconstriction sock 110, a padding sock 112, a piece of localized padding114, etc.), and/or any other suitable component. Indeed, in someembodiments, an external surface of the foot support comprises anadhesive that is configured to attach the foot support to a cast. Insome other embodiments, an internal surface of the foot supportcomprises an adhesive that is configured to attach the foot support to aportion of the underlayment 16 (e.g., a sock).

In yet another example (previously discussed), some embodiments of thefoot support 14 comprise an antimicrobial material (e.g., bamboo fabric,copper-coated fabric, silver-coated fabric, an antibiotic impregnatedmaterial, etc.). While this antimicrobial material can be disposed inany suitable location, in some embodiments, it is used as a covering onall or a portion of the foot support. By way of non-limitingillustration, FIG. 9G shows an embodiment in which the foot support 14comprises an antimicrobial material 108, adjacent to the offloading hole92.

In still another example, while the described foot support 14 isdescribed herein for use with a total contact cast (e.g., cast 12), thefoot support can be modified to be used with any suitable cast,including, without limitation, a known or novel cast for a broken leg,ankle, foot, or toe, a hand cast, an arm cast, etc. By way ofnon-limiting illustration (and skipping a little ahead in the figures),FIG. 11D shows that, in some embodiments, the foot support 14 is useablein virtually any known or novel casting system 300, including, withoutlimitation, in a conventional cast 302 that is spirally wrapped around abody part.

In even another example, while some embodiments of the foot support 14comprise a substantially flat portion on a which a patient's foot is tobe placed, in some other embodiments, the at least a portion of the footsupport is formed to contour or substantially contour to a portion(e.g., a sole) of a patient's foot. In this regard, the foot support canbe made in different generic sizes that allow it to be used for avariety of patients and/or the foot support can be custom fit forindividual patients. In this regard, the contour of the foot support canbe formed in any suitable manner, including, without limitation, throughthe use of heat, a press, a mold, and/or any other suitable method.

As yet another example of a suitable modification, in some embodiments,the foot support 14 comprises a rigid orthotic which optionally has oneor more layers of padding disposed thereon. While such a foot supportcan perform any suitable function, including (without limitation)providing support to a foot in a cast (e.g., cast 12), protecting aportion of a patient's foot (e.g., toes) from impacts, etc., in someembodiments, the foot support comprises a cast walker that allows apatient to walk on the cast, without the use of a separate boot and/orfootplate.

Where the foot support 14 comprises a cast walker, the foot support cancomprise any suitable characteristic. By way of non-limitingillustration (and jumping back in the figures to FIG. 9O), FIG. 9O showsa representative embodiment in which the foot support 14 comprises acast walker 95 having a rigid support 97; a rigid, semi-rigid, and/orresilient toe guard 94; and one or more optional layers of padding 99(e.g., which, in some embodiments, optionally define an offloading hole92). Additionally, while an undersurface of the cast walker can have anysuitable characteristic (e.g., be substantially flat, have one or morepedestals, contact surfaces, and/or other treads located proximally,anteriorly, in a middle of the foot support, and/or across any othersuitable portion of the undersurface), FIG. 9O shows that, in someembodiments, the cast walker 95 comprises one or more contact surfaces101 or treads that are somewhat centrally located on the walker.

Where the foot support 14 comprises a cast walker 95, the cast walkercan comprise any suitable material. In this regard, some examples ofsuitable materials include, but are not limited to, one or more rubbers,polymers, plastics, woods, metals, ceramics, synthetic materials,natural material, and/or any other suitable material. In someembodiments, however, the cast walker comprises rubber.

In even another example of a suitable modification, in some embodiments,the foot support 14 is attached to, is disposed within, is connected to,and/or otherwise comprises a portion of any suitable type of sock and/orany other suitable object. Accordingly, in some such embodiments, thesock and foot support can be slid onto a foot and/or another suitablebody part (e.g., a hand, arm, leg, etc.) to provide the body part withpadding and/or wound offloading.

In still another example of a suitable modification, an edge of the toeguard 94 that is configured to terminate over a dorsal portion of apatient's toe or foot) can have any suitable shape, including, withoutlimitation, be substantially squared (e.g., as shown in FIG. 9O,rounded, tapered, and/or otherwise shaped. In some embodiments, however,such an edge is tapered. While this edge can be tapered in any suitablemanner, FIG. 9Q shows that, in some embodiments, a portion of the toeguard 94 is thinned, beveled, tapered, and/or otherwise reduced inthickness to help reduce any pressure that can be applied to dorsal sideof a patient's toes and/or foot by such embodiments of the foot support14.

In addition to the characteristics previously mentioned, the describedfoot support 14 can have one or more other features. Indeed, in someembodiments, the foot support is configured to provide a patient with anoffloading hole 92 that is specifically placed to offload weight from awound on the patient's foot 32. As a result, some such embodiments canprovide a patient with an individualized foot support that allows awound on the patient's foot to heal faster that it may with someconventional casts.

As another example, the described toe guard 94 can protect a patient'stoes better from friction with a cast (e.g., the cast 12 and/or anyother suitable cast) or other damage and with less taping, or otherexternal forces, than may some conventional casts. As a result, someembodiments of the described foot support can help reduce healing time,while limiting the amount of additional damage that is caused to apatient's toes while the patient's foot is in a cast.

In still another example, while the foot support 14 is described hereinfor use with a cast (e.g., the described cast 12 and/or any othersuitable cast), the foot support can be used in any other suitablemanner, including, without limitation, by being used alone and/or with acast boot, a shoe, a bandage, and/or any other suitable element.

Cast Underlayment

With respect to the cast underlayment 16, the underlayment can compriseany suitable material or object that is configured to be disposedbetween an internal surface of a cast (e.g., the cast 12 and/or anyother known or novel cast and/or splint) and the skin of an appendagewithin the cast. Indeed, in some embodiments, the underlayment comprisesone or more articles configured to provide compression to an appendagewithin the cast, pieces of padding, negative pressure apparatus (e.g.,negative pressure socks, tubing, etc.), and/or other items that can bedisposed between the cast and a patient's skin. By way of non-limitingillustration, FIG. 10A illustrates an embodiment in which the castunderlayment 16 comprises a compression sock 110 (or other suitablecompression layer), a padding sock 112 (or other suitable paddinglayer), and localized padding 114. In this regard, in some embodimentsin which the underlayment comprises two or more components (or layers)the various components are configured to transfer shearing forces ormovements from between a cast (e.g., the described cast 12 and/or anyother suitable cast or splint) and the skin covered by the cast tobetween the two or more components of the underlayment. In suchembodiments, the described underlayment can reduce the maceration andother damage that can be caused by some conventional cast systems thatchafe against the skin they cover.

The various components (or layers) of the underlayment 16 (e.g., thecompression sock 110, padding sock 112, localized padding 114, etc.) canbe made of any suitable materials that allow the components to functionas intended. Some non-limiting examples of such materials includecotton, cellulosic fibers, gauze, polyurethane foam, neoprene,polyester, rayon, and/or one or more antimicrobial materials.

Where one or more components (or layers) of the underlayment 16 comprisean antimicrobial material (e.g., an anti-fungal, an anti-bacterialmaterial, a bactericide, and/or any other suitable antimicrobialmaterial), the underlayment can comprise any suitable antimicrobialmaterial. Some examples of such materials include, but are not limitedto, one or more bamboo fabrics and bamboo materials (e.g., bamboo cloth,bamboo rayon, polyester made from bamboo, and/or any other suitablefabric and/or material comprising bamboo), silver-coated materials(e.g., silver-coated poly(ethylene terephthalate), silver-coated rayon,silver-coated polyester, etc.), copper-coated materials,silver/copper-coated materials, silver/copper/nickel-coated materials,silver/copper/tin-coated materials, iodine incorporated materials,bactericide, and/or any other suitable antimicrobial material (e.g., asdiscussed above), including, without limitation, those antimicrobialmaterials having one or more anti-odor characteristics. In someimplementations, however, the underlayment comprises a bamboo-containingfabric. In this regard, each underlayment component can comprise anysuitable amount of bamboo (e.g., between about 0.1% and about 100%, orany sub-range thereof, including, without, limitation, between about 75%and about 99%).

In some embodiments (as mentioned above), the underlayment 16 comprisesone or more articles or layers that are configured to providecompression to an appendage within a cast (e.g., the described cast 12).In such embodiments, the underlayment can comprise any suitable articlethat is configured to provide pressure to an appendage within the cast.In some instances, however, this compression article comprises acompression sock, stockinette, tube, and/or sleeve (collectively andindividually a compression sock 110; a representative embodiment ofwhich is shown in FIG. 10B).

While the compression sock 110 can provide any suitable amount ofpressure to an appendage (e.g., lower leg 24), in some embodiments, thecompression sock is configured to provide compression to an appendage atany suitable pressure level. In this regard, in some embodiments, thecompression sock is configured to provide an appendage with betweenabout 5 mmHG and about 30 mmHG of pressure, or any sub-range thereof(e.g., between about 10 mmHG and about 20 mmHg, or even between about 10and 15 mmHG). Moreover, although in some embodiments, the compressionsock comprises a static compression sock that is configured to provide asubstantially constant compression across the appendage to which it isapplied, in other embodiments, the compression sock comprises asequential compression sock that is configured to provide greatercompression at a distal end of the sock (e.g., by a patient's toes).

In some embodiments (as mentioned above), the underlayment 16 comprisesone or padding layers or socks 112 (see e.g., FIG. 10C) that areconfigured to provide padding to an appendage within the cast (e.g.,cast 12). In such embodiments, the padding sock can comprise anysuitable article (e.g., sock, stockinette, sleeve, tube, sheet, etc.)that is configured to provide padding around a portion of an appendagewithin the cast (e.g., cast 12). Moreover, while the padding sock canprovide any suitable amount of padding, in some embodiments, the sock isconfigured to be between about 1 mm and about 3 cm thick (e.g., beforebeing applied to an appendage), or to have a thickness that falls in anysub-range thereof (e.g., between about 1.5 cm and about 2 cm).Additionally, although in some embodiments, the cast (e.g., cast 12and/or another suitable cast) is configured such that the padding sockis not bound to an internal surface of the cast, in other embodiments, aportion (if not all) of the padding sock becomes bound to the cast,either before or after the cast hardens.

While various components of the underlayment 16 can be made in anysuitable manner (e.g., via spinning, knitting, crocheting, weaving,sewing, extruding, etc.), in some embodiments, one or more components(e.g., the compression sock 110 and/or padding sock 112) are knittedand/or woven. Although this knitting and/or weaving process can beaccomplished in any suitable known or novel manner, in some embodiments,this process is done such that the various components of theunderlayment (e.g., the compression sock and padding sock) comprise aweave that is configured to be non-fraying (or to not significantly frayor unravel when such components are punctured or cut (e.g., at leastwhen such components are not cut completely around their perimeter). Asa result, in some such embodiments, the various components can be cut orpunctured (e.g., to allow medical tubing, such as a vacuum tube, a draintube, etc., to pass through one or more components) without causingsignificant damage to such components.

With respect to the localized padding 114, the underlayment 16 canoptionally comprise any suitable amount of additional padding in anysuitable location (e.g., over a patient's toes, dorsal portion of thepatient's foot, shin, calf, ankle, a lateral side of a proximal portionof a patient's fibula, an anterior portion of a proximal portion of apatient's tibia, and/or any other body part in the cast (e.g., cast 12))that could benefit from additional padding. While the additional paddingcan have any suitable relation with respect to the cast and one or morecomponents of the underlayment, in some embodiments, the localizedpadding is fixed to an internal surface of the cast (e.g., viastitching, an adhesive, tape, and/or any other suitable mechanism). Inthis regard, FIGS. 10D and 10E respectively illustrate embodiments inwhich an optional shin pad 116 and a full length pad 118 are attached toan internal surface 120 of the cast 12. In contrast, FIGS. 10F and 10Gshows an embodiment in which an optional shin pad 116 is configured tobe added to the cast 12, as desired. Moreover, FIGS. 11A-11C show that,in some embodiments, the localized padding 114 is attached to anotherportion of the underlayment (e.g., the compression sock 110 and/or thepadding sock 112). While such padding can be disposed in any suitablelocation, FIGS. 11A-11C shows that, in some embodiments, the additionalpadding 114 as configured to be placed over an ankle portion 72, a shinportion 70, and lateral leg portion 124 (e.g., over a proximal, lateralportion of a fibula and/or a tibia of a patient).

In addition to the aforementioned characteristics, the cast underlayment16 can be modified in any suitable manner that allows it to pad, provideshear reduction to, ventilate, and/or otherwise protect an appendagewithin a cast (e.g., cast 12). In one example of a suitablemodification, the various components of the underlayment 16 (e.g., thecompression sock 110, padding sock 112, and/or localized padding 114)can be used alone (e.g., with any combination of each other), with anysuitable combination of the elements of the described cast system 10,and/or with any other suitable cast, splint, and/or bandage system.Indeed, in some embodiments, one or more portions of the underlayment(e.g., a compression sock, padding sock, and/or localized paddingcomprising an antimicrobial material) is used as underlayment in a knownor novel: upper extremity cast (e.g., a short arm cast, a long arm cast,a finger spica, a thumb spica, etc.), lower extremity cast (e.g., a longleg cast, short leg cast, etc.), cylinder cast, body cast, spica,splint, and combinations thereof. In one non-limiting example, acompression sock and a padding sock comprising a bamboo material (and/oranother antimicrobial material) are used as underlayment in an arm cast.Similarly, in one non-limiting illustration, FIG. 11D shows anembodiment in which one or more components of the underlayment 16 (e.g.,the compression sock 110, the padding sock 112, and the localizedpadding 114) are useable in virtually any known or novel casting system300, including, without limitation, in a conventional cast 302 that isspirally wrapped around a body part.

In another example, in some embodiments, the first underlaymentcomponent (e.g., the compression sock 110) has a higher compression thanthe second underlayment (e.g., the padding sock 112). In some suchembodiments, such a configuration allows for an increased probabilitythat shear forces will be transferred to the interaction between thefirst underlayment component and the second underlayment component(and/or another underlayment component) instead of at an interfacebetween the skin and the first underlayment component.

In another example of a modification, any suitable portion of theunderlayment 16 (e.g., the compression sock 110, padding sock 112,and/or localized padding 114) can be removed from the cast system 10and/or any other component can be added to the system. Indeed, while theunderlayment can comprise two layers of material (e.g., a compressionand padding sock), in some embodiments, the underlayment comprises 3, 4,5, 6, 7, 8, or more layers. In some such embodiments, the additionallayers (e.g., one or more socks, stockinettes, sleeves, sheets, etc.)can perform any suitable purpose, including allowing shearing forces totake place between the various layers, as opposed to taking placeagainst a patient's skin as the cast moves with respect to such skin.

In still another example, in some embodiments, one or more components ofthe underlayment 16 comprise one or more holes that are preformed (e.g.,woven into, knitted into, cut into and then stitched to preventunraveling, and/or otherwise formed) in the various underlaymentcomponents. Accordingly, in some such embodiments, the variouscomponents can be used for ventilation and/or with medical tubing,without requiring that such components be punctured, cut, or torn toaccommodate such ventilation and/or tubing.

In yet another example of a suitable modification, the variouscomponents of the underlayment 16 can be placed on an appendage (e.g.,lower leg 24) in any suitable order. For instance, while FIG. 10Adepicts an embodiment in which the compression sock 110 is disposedclosest to the patient's lower leg 24 (not shown in FIG. 10A), with thepadding sock 112 disposed outside the compression sock 110, and withshin padding 116 and the foot support 14 disposed outside of the paddingsock, the order of such components can be reorganized in any suitablemanner. Indeed, in some instances, the foot support is disposed withinthe compression sock.

In another example, while, in some embodiments, each element of theunderlayment 16 (e.g., the compression sock 110, padding sock 112, andlocalized padding 114) is used together (e.g., in a cast, splint, shoe,prosthetic, ski boot, rollerblade/roller-skate boot, in a post-operationsetting, and/or other suitable environment), in some other embodiments,the various components of the underlayment are used individually and/orin any other suitable combination (e.g., to reduce shear damage that canbe caused to a person's skin when such skin is in close proximity toanother object, such as an interior of a prosthetic, a hiking boot, aski boot, etc.). By way of non-limiting illustration (and returning backto FIG. 1C, that figure shows an embodiment in which the optionallocalized padding 114 is omitted and the compression sock 110 and thepadding sock 112 are used in the described cast 12 (e.g., to provide forshear reduction between a patient's skin (not shown in FIG. 1C) and aninternal surface of the cast 12).

In still another example, while some embodiments of the underlayment 16can move completely independently of the cast 12 (or another suitablecast, splint, and/or bandage), in some other embodiments, one or morecomponents of the underlayment are at least partially attached to thecast when the cast and underlayment are disposed on an appendage. Inthese latter embodiments, any suitable portion of the underlayment(e.g., the compression sock 110, the padding sock 112, and/or thelocalized padding 114) can be attached to the cast, in any suitablemanner (e.g., via one or more adhesives, pieces of tape,tackifiers/hardening materials in the casting material, mechanicalattachments, frictional attachments, etc.). As a result, in someembodiments, the described underlayment is able to reduce shearingforces between the cast and the patient's skin.

In yet another example of a suitable modification, some embodiments ofthe compression sock 110, the padding sock 112, and/or the localizedpadding 114 comprise and/or are configured to comprise (e.g., viacutting, tearing, separating perforated lined, and/or otherwiseconfigured to define) an offloading hole that is configured tocorrespond in position to a wound on an appendage using suchcomponent(s). In this manner, one or more components of the underlayment16 can help offload at least some weight/pressure from a wound, anddistribute such weight/pressure to another portion of the appendageusing such component(s).

Each of the various components of the underlayment 16 can optionally bemodified in any suitable manner that allows them to define an offloadinghole 92 that can correspond in position to a wound on an appendage(and/or any other suitable body part). In one example, one or morecomponents of the underlayment are manufactured to include one or moreoffloading holes. In another example, however, some embodiments of oneor more of the underlayment components are easily customizable, suchthat one or more portions of the various underlayment components can beremoved to provide an offloading hole. In such embodiments, the variousportions of the underlayment can be removed in any suitable manner,including, without limitation, by removing portions of the compressionsock 110, the padding sock 112, and/or the localized padding 114 withscissors, a knife, a punch, and/or another cutting instrument. In someembodiments, however, one or more of the underlayment componentscomprise one or more perforated portions that are easily torn, cut,and/or otherwise separated to release one or more portions of suchcomponent(s). By way of non-limiting illustration, FIG. 10G shows anembodiment in which the optional localized padding 114 comprises aplurality of perforated lines 117 that allow one or more portions of thepadding to be removed to create an offloading hole (not shown) that cancorrespond in position to a wound.

In addition to the characteristics previously mentioned, the describedcast underlayment 16 can have several features. Indeed, in one example,where one or more portions of the underlayment (e.g., the compressionsock 110, the padding sock 112, and/or the localized padding 114)comprise an antimicrobial material (e.g., a bamboo fabric), theunderlayment may help combat infection, odor, bacteria, fungus, excessmoisture, and/or otherwise help wounds on the bandaged appendage toheal. Additionally, in some embodiments in which one or more componentsof the underlayment comprise bamboo or another breathable fabric(including, without limitation, a fabric that is formed with ventilationholes in it), the cast system 10 can provide better ventilation than maysome conventional casts that simply comprise a cotton underlayment. As aresult, of the foregoing, some embodiments of the described underlaymentcan improve healing time and/or reduce the costs associated with certainhealing procedures.

In yet another example of a beneficial characteristic of theunderlayment 16, in some implementations in which the underlaymentcomprises 2, 3, 4, 5, or more layers of one or more materials (e.g., oneor more compression sock 110, padding socks 112, localized padding 114layer, etc.), the underlayment functions as a multi-layer shearreduction system, allowing shearing movement between the skin of acasted appendage and the cast itself to take place between the multiplelayers of the underlayment (e.g., the padding sock 110 and thecompression sock 112). As a result, some embodiments of the describedunderlayment can dramatically reduce the skin damage that is oftencaused by some conventional casts.

Footplate/Boot

With respect to the footplate and boot 18, the footplate and/or boot cancomprise any suitable component that allows a patient to wear thefootplate and/or boot on a wounded foot/leg. With respect to thefootplate, the footplate can include any suitable component orcharacteristic that allows it to support a patient's foot. Indeed, insome embodiments, the footplate comprises a top plantar surface and anundersurface. In this regard, the top surface can include any suitablecharacteristic that allows the footplate to support a patient's foot. Byway of non-limiting illustration, FIG. 12A shows that, in someembodiments, the footplate 124 defines an indentation (or a heel cup126) towards the plate's posterior end 128. While this indentation canperform any suitable function, in some embodiments, it is configured tocradle a patient's heel and/or to help ensure that the patient's heel iscorrectly positioned on the orthopedic footplate 124 (i.e., when thefoot is first placed on the footplate and as the patient walks).

While the undersurface of the footplate 124 can comprise any suitablecharacteristic that allows a patient to walk on the footplate, in someembodiments, the footplate comprises a cam-shaped undersurface. In thisregard, an eccentric portion of the cam-shaped undersurface can bedisposed in any suitable location (e.g., posteriorly, medially,laterally, anteriorly, in the middle of the footplate, etc.) that allowsthe patient to walk and/or slide the patient's foot across a surface. Byway of non-limiting illustration, FIGS. 12B, 12C, and 12D respectivelyshow embodiments in which the eccentric portion 130 of the footplate 124is disposed anteriorly, in the middle, and posteriorly on the footplate124.

As another example of a suitable characteristic of the footplate 124,the footplate can have any suitable thickness that allows a patient towalk on it. Indeed, in some embodiments, the distance (as shown by D inFIG. 12B) between a highest point on the top surface 132 of thefootplate upon which a patient places the patient's foot and a lowestpoint 134 on the undersurface 136 of the footplate is between about 1 mmand about 5 cm. Moreover, the distance D between the highest point onthe top surface and the lowest point on the undersurface of thefootplate can fall in any sub-range of the aforementioned range (e.g.,between about 0.3 and about 1.5 cm). Indeed, in some embodiments, thedescribed footplate is relatively thin (e.g., between about 0.4 andabout 0.8 cm), thus, reducing any limb length discrepancy between apatient's leg that is using the footplate and (where the patient onlywears the footplate on one foot) the patient's leg that is not wearingthe footplate.

As yet another example of a suitable characteristic of the footplate124, the footplate can attach to a cast (e.g., the described cast 12and/or any other suitable cast), a splint, a leg, a foot, and/or anyother suitable object in any suitable manner that allows it to be usedas intended. Indeed, although in some embodiments, the footplate andcast (e.g., cast 12) are integrally connected (e.g., via one or moreadhesives, pieces of tape, types of welding, types of stitching,mechanical fasteners, and/or any other suitable mechanism), in otherembodiments, the two components are selectively attachable (e.g., viaone or more straps, hook and loop fasteners, cords, etc.). In oneexample, FIG. 12E shows the cast 12 and footplate are attached via anadhesive (not shown), a hook and loop fastener (not shown), a piece oftape (not shown), a portion of the footplate being wrapped within aportion of the cast (not shown), and/or in any other suitable manner. Inanother example, FIGS. 12F and 12G show that (in some embodiments) thefootplate 124 is configured to receive one or more straps, cords, and/orother binding 138 (e.g., in the binding indentations 140 or otherwise)that are wrapped around a portion of the footplate and cast to securethe footplate to the cast.

As another example of a suitable method for connecting the footplate 124to a cast, leg, and/or another suitable component, in some embodiments,the footplate comprises one or more upright supports that allow thefootplate to be anchored to a patient's leg. In this manner, thefootplate can be used as a boot 18.

While the upright supports can comprise any suitable component, FIGS.12J through 12L show that some embodiments of the upright supports 142are configured to be attached to one or more attachment mechanisms 144,which may include, but are not limited to, 1, 2, 3, 4, 5, 6, 7, 8, ormore straps, cords, and/or other devices that are capable of securingthe upright supports to a patient's leg/cast. Additionally, FIG. 12Lshows that some embodiments of the upright supports 142 include and/orare attached to one or more flaps 146 (e.g., lateral/medial flaps 148,posterior flaps 150, and/or anterior flaps 152, as respectively shown inFIGS. 12M, 12N, and 12O) that help distribute pressure on the uprightsupports across a portion of the patient's leg to further offload weightfrom a wound on the patient's foot. In some such embodiments, the flapscan have any suitable characteristic. Indeed, in some embodiments, oneor more of the internal surfaces of the flaps (e.g., the surfaces thatare configured to interface with the cast) comprises a material,texturing, and/or other feature that allows it to maintain its positionwith respect to the cast (e.g., as the patient walks in the boot).

The described footplate 124/boot 18 can be modified in any suitablemanner that allows it to fulfill its intended purpose. In one example,the footplate/boot can be modified to include any and/or all componentsof the described cast system 10. For instance, in some embodiments(e.g., as shown in FIG. 12K), the foot support 14 is attached to thefootplate 12. In another example, the footplate is attachable to anysuitable and known or novel slipper, sandal, shoe, overshoe (e.g.,galoshes), slide, and/or other footwear/cast wear. By way ofnon-limiting illustration, FIG. 12Q shows a representative embodiment inwhich the footplate 124 is attached to a shoe 154.

Associated Methods

The various components of the described cast system 10 can be used inany suitable manner that allows the components (individually or incombination) to help protect a wounded portion of a patient's body. Inthis regard, the various components of the described cast system can beused in any suitable combination, meaning that virtually any portion ofthe cast system can be omitted, any portion of the cast system can bereplaced with one or more other known or novel components, and that anysuitable component (including, without limitation, any suitable wounddressing, primary contact wound dressing, cast, underlayment, boot,footplate, sock, shoe, ointment, negative pressure mechanism, positivepressure mechanism, and/or any other suitable mechanism, medicine,and/or treatment) can be added to (or used with) one or more componentsof the described cast system.

While the described components of the cast system 10 can be applied apatient in any suitable manner, FIG. 13 illustrates some embodiments ofa method 198 for placing the cast system on a patient. This method,however, can be modified in any suitable manner (including byrearranging, adding to, removing, substituting, and/or otherwisemodifying one or more portions of the method).

As shown at step 202 in FIG. 13, in at least some embodiments, themethod 198 optionally begins at step 200 by applying any suitable andknown or novel wound dressing (e.g., a primary contact wound dressing)to the wound. Step 202 shows that, in some embodiments, the method 198continues by providing one or more elements of the described cast system10 (e.g., the cast 12, foot support 14, compression sock 110, paddingsock 112, localized padding 114, boot 18, and/or footplate 124).

Step 204 shows that in some embodiments in which the cast system 10comprises a foot support 14, the method 198 continues as the footsupport is optionally tailored for the patient's foot. While the footsupport can be tailored for the patient's foot in any suitable manner,in some embodiments, a patient's foot is placed on the foot support(e.g., somewhat posterior to an anterior end of the foot support toavoid to impingement), an outline of the patient's foot is made on thefoot support, and portions of the foot support that fall outside of theoutline are removed (e.g., via tearing perforations 102, cutting thesupport with scissors, etc.). In some embodiments in which the patient'sfoot comprises a wound, the location of the wound is determined, and acorresponding portion of the foot support is removed to create anoffloading hole 92. Additionally, in some embodiments, once the footsupport has been cut to match an outline of the patient's foot and anoffloading hole has been created, the foot support is placed up againstthe patient's foot to ensure that the foot support has been properlytailored.

Continuing with the method 198, step 206 shows that in some embodimentsin which the method includes applying a compression sock 110, the sockcan be applied (e.g., to a bandaged or un-bandaged lower leg 24). Whilethis sock can be applied in any suitable manner, in some embodiments,the compression sock is rolled, slid, and/or otherwise placed on thepatient such that the patient's toes can receive proper ventilation.

At step 208, FIG. 13 shows that in some embodiments in which the castsystem 10 comprises a padded sock 112, the padded sock is applied to thepatient's leg (e.g., over the compression sock 110). While the paddedsock can be applied in any suitable manner, in some embodiments, aproximal portion of the sock (e.g., a portion that is adjacent to thepatient's knee) is folded back on itself, distal to the patient's knee(e.g., one to three fingers width below the patient's fibula head).

At step 210, FIG. 13 shows that, in some embodiments in which the castsystem 10 comprises a piece of localized padding 114 (e.g., a shin pad116), the localized padding is optionally applied to the patient's lowerleg 24. While the localized padding can be applied in any suitablemanner, in some embodiments, the localized padding comprises an adhesivethat allows it to adhere to a surface (e.g., to a surface of the paddingsock 112). Additionally, in some embodiments, a portion of the localizedpadding is tucked under the folded back portion of the padding sock.

At step 212, FIG. 13 shows that in some embodiments in which the castsystem 10 comprises the foot support 14, the patient's foot (e.g., afoot that is covered with the compression sock 110 and the padding sock112) is placed on the foot support 14.

Continuing with the method 198, step 214 shows that, in some embodimentsin which the cast system 10 comprises the clam-shell cast 12, the castis applied to the patient's lower leg 24. While the cast can be appliedto a patient in any suitable manner, FIGS. 14A-14F show that, in someembodiments, once the casting material 18 is ready (e.g., wetted;removed from an air-tight package, a foil package, and/or other suitablepackage; and/or otherwise prepared), the patient's leg 24 is placed onthe unfolded cast 12 (e.g., as shown in FIG. 14A), and the second 26 andthird 34 portions of the elongated casting material 18 are folded overthe dorsal portion 38 and shin portion 70 (e.g., as shown in FIG. 14B).

While the straps 48 and 50 can be wrapped around the cast 12 in anysuitable manner, in some embodiments, the straps are configured to bematched and wrapped around or with each other. In this regard, thevarious portions of each strap can be matched, wrapped, and/or otherwiseconnected with any other portion of itself and/or any other strap. Insome embodiments, however, one or more straps are optionally marked toindicate which straps should be matched and/or connected with eachother. In this regard, the various straps can be marked in any suitablemanner that allows them to be readily matched. Indeed, in someembodiments, the straps matching straps comprise one or more matchingmarkings (e.g., symbols, letters, words, and/or other markings),matching colors (e.g., colors of material and/or thread), and/or anyother suitable matching mechanism that allows a user (e.g., a medicalpractitioner) to quickly identify which straps match and/or should beconnected with each other. By way of non-limiting illustration, FIG. 14Ashows some embodiments in which the straps 48 and 50 comprise a strapmatching mechanism 220 in which straps (e.g., straps 48 and 50) thatshould be connected together are marked with the same letter (e.g., A,B, C, or D).

In any case, FIGS. 14C-14D show that, in some embodiments, the straps 48and 50 are wrapped into position while the foot is kept at a suitableangle (e.g., about 90±10 degrees) with respect to the leg, cuts 62 ornotches 60 are formed at the heel or other bend points (e.g., FIG. 14E),additional casting material (not shown) is optionally removed from oneor more portions of the cast, additional casting material is rolled orotherwise placed on one or more portions of the cast (e.g., in someembodiments, strengthening the cast and/or covering one or more holes 64or openings in the cast), and/or a proximal end of the compression sock110 is folded over a proximal end of the cast 12 (e.g., FIG. 14F). Insome embodiments, water is also applied to the cast to smooth the castout before it hardens.

Returning to FIG. 13, step 216 shows that, in some embodiments, themethod 198 continues as the cast 12 is placed in a boot 18 and/orfootplate 124 (e.g., as shown in FIG. 1A). In this regard (and asdiscussed above), the cast be placed in any known or novel boot that issuitable for use with the cast. Additionally, in some embodiments, themethod 198 is repeated one or more times to help a wound to heal.

The various components of the described cast system 10 can be formed inany suitable manner, including, without limitation, through weaving,knitting, extrusion, molding, heating, pressing, wrapping, cutting,folding, sewing, scoring, adhering, perforating, attaching withfasteners, bending, and/or any other suitable technique. Additionally,although, in some embodiments, one or more components of the describedcast system are sterilized before being brought to market, in some otherembodiments, one or more components of the cast system are leftunsterilized.

Thus, the present invention relates to orthopedic casts. In particular,some implementations of the present invention relate to one or morecomponents of a total contact cast system that can be used in thetreatment of an appendage, such as a leg or foot. More particularly, insome implementations of the described casting system are configured tosupport a patient's foot and leg, while offloading weight from a sore,ulcer, and/or wound on the patient's foot.

In addition to any previously indicated modification, numerous othervariations and alternative arrangements may be devised by those skilledin the art without departing from the spirit and scope of thisdescription, and appended claims are intended to cover suchmodifications and arrangements. Thus, while the information has beendescribed above with particularity and detail in connection with what ispresently deemed to be the most practical and preferred aspects, it willbe apparent to those of ordinary skill in the art that numerousmodifications, including, but not limited to, form, function, manner ofoperation, and use may be made without departing from the principles andconcepts set forth herein. Also, as used herein, the examples,implementations, and embodiments, in all respects, are meant to beillustrative only and should not be construed to be limiting in anymanner. In addition, as the terms on, disposed on, attached to,connected to, coupled to, etc. are used herein, one object (e.g., amaterial, element, structure, member, etc.) can be on, disposed on,attached to, connected to, or coupled to another object—regardless ofwhether the one object is directly on, attached, connected, or coupledto the other object, or whether there are one or more interveningobjects between the one object and the other object. Also, directions(e.g., on top of, below, above, top, bottom, side, up, down, under,over, upper, lower, lateral, medial, vertical, horizontal, distal,proximal, etc.), if provided, are relative and provided solely by way ofexample and for ease of illustration and discussion and not by way oflimitation. Furthermore, where reference is made herein to a list ofelements (e.g., elements a, b, c), such reference is intended to includeany one of the listed elements by itself, any combination of less thanall of the listed elements, and/or a combination of all of the listedelements. Also, as used herein, the terms a, an, and one may each beinterchangeable with the terms at least one and one or more. It shouldalso be noted, that while the term step is used herein, that term may beused to simply draw attention to different portions of the describedmethods and is not meant to delineate a starting point or a stoppingpoint for any portion of the methods, or to be limiting in any otherway.

What is claimed is:
 1. An orthopedic cast comprising: a piece of castingmaterial configured to extend over and provide a protective cast arounda body part; and a cast underlayment, wherein the cast underlayment isconfigured to be disposed between an internal surface of the cast andthe body part, and wherein the cast underlayment comprises anantimicrobial material.
 2. The cast of claim 1, wherein theantimicrobial material is selected from a bamboo material, asilver-coated fabric, a copper-coated fabric, a silver/copper-coatedfabric, a silver/copper/nickel-coated fabric, a silver/copper/tin-coatedfabric, and combinations thereof.
 3. The cast of claim 1, wherein theantimicrobial material comprises a bamboo material.
 4. The cast of claim1, wherein the cast underlayment comprises a compression sock.
 5. Thecast of claim 1, wherein the cast underlayment comprises a paddinglayer.
 6. The cast of claim 1, wherein the cast underlayment comprisesboth a compression sock and a padding layer.
 7. The cast of claim 6,wherein the padding layer is at least partially disposed on an outersurface of the compression sock.
 8. The cast of claim 7, wherein atleast a portion of the padding layer is coupled to the internal surfaceof the cast, and wherein the padding layer and the compression sock areindependently movable within the cast such that at least some shearingmovement between skin of the body part and the cast itself is configuredto take place between the padding layer and the compression sock.
 9. Anorthopedic cast comprising: an orthopedic cast comprising a hardenablepiece of casting material that is configured to extend over and providea protective layer around a body part; and a multi-layer shear reductionsystem disposed within the orthopedic cast, the multi-layer shearreduction system, comprising: a first underlayment component configuredto extend over a portion of the body part; and a second underlaymentcomponent disposed between the first underlayment component and aninterior surface of the orthopedic cast, wherein the first underlaymentcomponent and the second underlayment component are capable of movingindependently of each other within the cast such that at least someshearing movement between skin of the body part and the cast itself isconfigured to take place between the padding layer and the compressionsock.
 10. The cast of claim 9, wherein the first underlayment componentcomprises a compression sock.
 11. The cast of claim 10, wherein thefirst underlayment comprises an antimicrobial material.
 12. The cast ofclaim 11, wherein the first underlayment comprises a bamboo material.13. The cast of claim 9, wherein the second underlayment componentcomprises a padding layer.
 14. The cast of claim 13, wherein a portionof the padding layer is bound to an internal surface of the orthopediccast.
 15. The cast of claim 9, wherein the cast comprises a totalcontact cast.
 16. The cast of claim 9, wherein the first underlaymentcomponent comprises a non-fraying weave.
 17. An orthopedic cast,comprising: an orthopedic cast comprising a hardenable piece of castingmaterial that is configured to extend over and provide a protectivelayer around a body part; a compression sock; and a padding sock,wherein the compression sock and the padding sock are disposed with theorthopedic cast, such that a portion of the compression sock isconfigured to be disposed closer to the body part than the padding sockand such that the compression sock and the padding sock are capable ofmoving independently of each other within the cast.
 18. The cast ofclaim 17, wherein at least one of the compression sock and the paddingsock comprises an antimicrobial material.
 19. The cast of claim 18,wherein the antimicrobial material is selected from a bamboo material, asilver-coated fabric, a copper-coated fabric, a silver/copper-coatedfabric, a silver/copper/nickel-coated fabric, a silver/copper/tin-coatedfabric, and combinations thereof.
 20. The cast of claim 18, wherein boththe compression sock and the padding sock comprise a bamboo material.21. A cast underlayment comprising: a cast underlayment that isconfigured to be disposed between an internal surface of an orthopediccast comprising a hardened piece of casting material and a body partthat is covered by the orthopedic cast, wherein the cast underlaymentcomprises an antimicrobial material, and wherein the cast underlaymentcomprises a non-fraying weave.
 22. A cast underlayment comprising: acast underlayment sock that is configured to be disposed between aninternal surface of an orthopedic cast comprising a hardened piece ofcasting material and a body part that is covered by the orthopedic cast,wherein the cast underlayment comprises a piece of additional paddingdisposed at a portion of the underlayment sock that is configured toextend over a proximal, lateral portion of a lower leg when theunderlayment sock is disposed on the lower leg.
 23. A piece oforthopedic casting material comprising: an elongated piece of hardenablecasting material comprising an inner surface and an outer surface,wherein the inner surface is configured to face a body part when thehardenable casting material is applied to the body part to form a cast,and wherein a padding layer is fixedly attached to the inner surface ofthe hardenable casting material before the casting material is appliedto the body part to form the cast.